Major Depressive Disorder
Conditions
Brief summary
This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist. The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.
Interventions
OTHERaTMS utilizing the MagVenture TMS device
Participants will complete 6 MagVenture TMS sessions per day for 5 days at the SLP Clinic. Sessions will take place with at least 30 minutes between each session. The first session will determine the baseline motor threshold for delivering aTMS. We will be stimulating the dorsolateral prefrontal cortex (DLPFC) which is within the FDA approved uses. Participants will complete a PHQ9 on all 5 treatment days and 1, 2, 4, and 6 weeks post treatment via REDCap Participants will complete daily adverse event logs via REDCap
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 70 years old * Current patient of SLP Clinic * Diagnosis of Unipolar Depression * Have tried at least 1 antidepressant * Ability to maintain stable medication regimen for duration of study
Exclusion criteria
* Has received TMS in the last 3 months * Diagnosis of Bipolar Depression * Any lifetime psychosis or mania * Recent suicide attempt within 90 days of study visit * Use of Benzodiazepines in past 4 weeks * Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures * Current or history of alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in depressive symptoms | baseline and 6 weeks | assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability data of aTMS | 0, 1, 2, 4, and 6 weeks post treatment | — |
| Dropout rate | 6 weeks | will be calculated via completion rates |
Countries
United States
Outcome results
None listed